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New fetal heart monitor could unlock secrets of stillbirth

NCT ID NCT03775954

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new, non-invasive monitor (fetal magnetocardiography) to detect hidden heart problems in high-risk pregnancies that might lead to fetal death. Researchers will study 30 pregnant women with conditions like congenital heart disease or twin pregnancy. The goal is to find early warning signs to prevent stillbirth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2018

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Current pregnancy complicated by one of the five diagnostic categories (fetal major congenital heart disease, prior unexplained Stillbirth at/after 20 weeks gestation, fetal hydrops, fetal gastroschesis, or monochorionic twin pregnancy.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Current pregnancy complicated by one of the five diagnostic categories * prior unexplained Stillbirth at/after 20 weeks gestation * fetal major congenital heart defect * fetal hydrops * fetal gastroschisis * monochorionic twin pregnancy * Subject must be 18 years of age or older * Subject must be English speaking and must be able to read and sign the consent form in English * Subject must be able to recline comfortably for 1-3 hours * Subject must be willing to complete all three procedures (fMCG, fMCG, nECG) as per protocol, unless medically unable * Subject must be willing to allow us to review her and her infants prenatal, deliver, and post-natal records to verify diagnosis, and clinical findings. Exclusion Criteria: * Severe claustrophobia not reduced by taking breaks, or by having the light on, or by having someone in the room with them. * Active labor * Acute illness * Unable to recline comfortably with a pillow for more than 1-3 hours (assuming some breaks are provided) * Weight over 450 lbs * An electric stimulation device (TENS unit, pacemaker, or nerve stimulator) that could produce electric or magnetic noise. * Note that the Tristan 624 Magnetometer does not pose a risk to the subject's device, (since fMCG does not produce any energy or magnetism), but stimulators themselves can cause interference for our recordings. Some devices may still qualify, and discussion with study nurse may be useful if subject has a pacemaker or similar device. The subject will have a single 2-3 hour fetal magnetocardiogram at approximately 20 and 27 weeks GA, and again, if medical condition allows, between 30 and 37 weeks GA, then her infant will have an ECG between 0 and 4 weeks of age. Subjects will be paid a nominal fee for their participation each time, as well as transportation reimbursement if \>25 miles. For subjects traveling a long distance, the ECG may be performed locally or at home.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • University of Wisconsin - Madison

    RECRUITING

    Madison, Wisconsin, 53715, United States

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